GW Pharmaceuticals (GWPH) and its commercial partner, Almirall S.A., presented data from a new multiple sclerosis (MS) study on Sativex at the 29th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (:ECTRIMS).
The data showed that Sativex was effective in improving the spasticity symptoms in patients suffering from MS in the long run while maintaining its safety profile. While improving the spasticity symptoms, Sativex did not impact the patients’ driving ability, cognition or mood.
We note that Sativex is already approved in 22 countries for the treatment of spasticity due to MS.
Data from a phase IV, 50 weeks, double-blind, randomized, placebo-controlled study showed that Sativex (average dose 6.4 spray/day) was identical to placebo both in cognition and mood scales, and was comfortably tolerated.
Additionally, data from another prospective and observational new study, held across centers in Germany, showed that Sativex had no adverse impact on patients’ ability to drive and improved MS spasticity and spasms count.
We note that GW Pharma has a licencing agreement with Almirall S.A. for Sativex. As per the agreement, Almirall has the exclusive rights to market the drug in the European Union (excluding the UK), EU accession countries as well as Switzerland, Norway and Turkey. Almirall also has the rights to market the drug in Mexico. However, GW Pharma holds the rights to manufacture and supply Sativex to Almirall.
Sativex was also in the news last month when GW Pharma announced about a new pricing agreement for Sativex in Germany. As per the agreement, a mutually-acceptable reimbursement price has been agreed upon between Almirall S.A. and the German National Association of Statutory Health Insurance Funds (GKV-SV).
Alimirall had objected to the reduced price of Sativex enforced by the German authorities in Mar 2013. The newly announced agreement resolved this issue thereby resulting in an increase in prices.
GW Pharma also filed a phase III Investigational New Drug (IND) application with the U.S. Food and Drug Administration (:FDA) in Aug 2013 to evaluate Sativex for MS spasticity.
Meanwhile, GW Pharma is also conducting two phase III studies on Sativex in the U.S. for treating pain in cancer patients. The company expects top-line results from these studies by next year, after which it will file a New Drug Application in the U.S.
GW Pharma carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. (ALIOF) and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #1 (Strong Buy), and Sarepta Therapeutics, Inc. (SRPT) with a Zacks Rank #2 (Buy).